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art bicarbonate for hemodialysis art bicarbonate liquid for hemodialysis
Advanced Renal Technologies
Summary: art bicarbonate for hemodialysis is a liquid used in dialysis to maintain acid-base balance. It is primarily used in hemodialysis settings. Key evidence highlights its role in correcting electrolyte and acid-base abnormalities.
FDA Clearance Information
Pathway
510K
Number
K010760 ↗
Decision Date
June 11, 2001
Product Code
KPO
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on June 11, 2001. It is manufactured by Advanced Renal Technologies and classified as a Class 2 device.
What It Is
art bicarbonate for hemodialysis is a liquid formulation used during hemodialysis to help maintain the acid-base balance in patients with renal failure. It is designed to correct the composition of uremic blood to physiological levels.
Clinical Applications
This device is commonly used in hemodialysis settings to manage patients with end-stage renal disease. It helps in maintaining electrolyte balance and preventing complications associated with acid-base imbalances.
Evidence Summary
The available literature includes a range of study types such as RCTs and retrospective studies, with a total of 5 studies reviewed. The studies span from 1994 to 2015.
Reported Outcomes
Published studies report that art bicarbonate for hemodialysis effectively corrects electrolyte and acid-base abnormalities in patients undergoing dialysis. It is noted for its role in achieving physiological blood composition and maintaining cardiovascular stability during dialysis.
Safety Profile
Reported complications include potential issues related to sodium balance, which is crucial for cardiovascular stability during dialysis. However, specific adverse events are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data in the reviewed studies. Further research is needed to explore long-term efficacy and safety, as well as patient-specific outcomes.
Frequently Asked Questions
What are the clinical indications for art bicarbonate for hemodialysis?
art bicarbonate for hemodialysis is indicated for use in maintaining acid-base balance during hemodialysis in patients with renal failure.
What outcomes have been reported in clinical studies?
Studies report effective correction of electrolyte and acid-base abnormalities, contributing to physiological blood composition during dialysis.
What complications have been reported?
Safety data from evidence indicate potential issues with sodium balance, but specific adverse events are not detailed.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.